Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) is stepping into clinical-stage biotech after reporting promising results from its first-in-human trial of Targeted Hyperthermia Therapy (THT) for advanced melanoma.
The early feasibility study treated 10 patients whose melanoma had not responded to standard immunotherapies.
By day 15, eight patients showed a strong clinical response, with six seeing complete elimination of cancer in biopsied tumors. Two patients did not respond.
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“This really is a moment for us where we graduate from being a preclinical life sciences company to a clinical stage life sciences company,” CEO David Regan told Proactive.
Sona’s THT uses biocompatible gold nanorods inserted into tumors, which are then activated with near-infrared light. The gentle heat, between 42 and 48°C, selectively kills cancer cells while sparing healthy tissue and stimulates the immune system to attack the tumor. Unlike conventional immunotherapies, THT is minimally invasive, safe, and has shown responses even in patients who had exhausted other options.
“What happens when you kill those cancer cells at that gentle heat level is there's a natural unraveling and apoptotic cell death that reveals new antigens that the body's immune system hasn't yet seen, causing the immune system to engage,” Regan said.
The company is preparing a Canadian clinical trial to explore THT in a broader range of solid tumors, with approval from Health Canada pending. The next study will also refine the therapy’s delivery based on clinician and patient feedback from the first trial.
“These results open so many doors for us. It's not just melanoma. We think we can have broad appeal for this therapy to a number of immune therapy resistant solid tumor types,” Regan added, highlighting the potential for Sona to expand THT’s application beyond melanoma.
While the trial involved a smaller number of patients, the results signal a potentially important step for Sona as it looks to expand its cancer-fighting technology and attract investor attention in the competitive biotech sector.